MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CNA0T0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during an intraocular lens (iol) implantation procedure, the haptic was found to be bent or crimped.There was patient contact, and the procedure was completed on the same day.Additional information was requested.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious malfunction.No further reports required.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received as the initial reporter was referring to the staff's experience, noting that eye procedures are performed three times a week (monday, wednesday, and friday).This was not intended to suggest that the event occurred three times a week.As there is no product-related issue identified, the file will be closed as cancelled.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The product was returned for analysis, and a straight leading haptic was observed.The device was received in an opened blister tray inside the product carton.Solution was dried in the device.The lock-out assembly had been removed.The plunger and the lens had been advanced into the mid-nozzle.The plunger position was acceptable.The trailing haptic was folded onto the optic, and the leading haptic was extended straight.The plunger, lens, and haptic positions were acceptable.The presentation of straight leading haptics is addressed in the product instructions for use (ifu), which state that delivery may proceed with caution and should be managed according to the outlined instructions.While straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible contributing factors may include: use of a non-qualified viscoelastic or bss in the delivery system.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Excessive delay between device preparation and delivery, potentially leading to haptic unfolding.Use of the delivery system at operating room temperatures outside the recommended range of eighteen degrees celsius (sixty-four degrees fahrenheit) to twenty-three degrees celsius (seventy-three degrees fahrenheit).Ovd should be allowed to reach room temperature over a 20-minute period before use.Any of the above factors, alone or in combination, may led to an event such as the one reported.Based on the product history record, the product met release criteria.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
A supplementary medical device record (smdr1) was submitted initially as the initial complaint was deemed invalid.Upon further review, the file was determined to be a valid complaint.Additional reports will be submitted accordingly.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL WITH THE AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22321228
• Report Number: 9612169-2025-01281
• Device Sequence Number: 15658212
• Product Code: HQL
• UDI-Device Identifier: 00380652393676
• UDI-Public: (01)00380652393676(17)280224(11)250225(10)26000842
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CNA0T0
• Device Lot Number: 26000842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/27/2025; 07/25/2025; 09/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/04/2025; 08/19/2025; 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown